This study is being initiated to provide continued access to ritonavir-boosted elvitegravir (EVG/r; GS-9137/r) for those participants currently benefiting from their participation in an ongoing EVG/r study. This study will also provide initial access to EVG/r for those participants who have completed a EVG/r study in which the participant was participating in a treatment arm that did not include EVG/r.

While on study, participants will be monitored for safety using periodic assessments of concomitant medications, adverse events and laboratory tests. Participants will be seen once every 8 weeks for the first 48 weeks of the study. Upon completion of 48 weeks, study visits will occur once every 12 weeks until EVG becomes commercially available, or until Gilead elects to terminate the study.

A Phase 2, Open-Label, Multicenter Study of the Safety of Ritonavir-Boosted GS-9137 (GS-9137/r) Administered in Combination With Other Antiretroviral Agents for the Treatment of HIV-1 Infected Subjects

Incidence of treatment-emergent laboratory toxicity [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]

Incidence of treatment-emergent laboratory abnormalities, defined as values that increase at least one toxicity grade from baseline at any time post baseline up to and including the date of last dose of study drug plus 30 days, will be summarized. Graded laboratory abnormalities will be defined using the GSI Grading Scale for Severity of Adverse Events and Laboratory Abnormalities.

Incidence of marked treatment-emergent laboratory toxicity [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]

Incidence of marked treatment-emergent laboratory abnormalities, defined as a shift from a baseline Grade 0 to a post-baseline Grade 3 or Grade 4 or from a baseline Grade 1 to a post-baseline Grade 4, will be summarized. Graded laboratory abnormalities will be defined using the GSI Grading Scale for Severity of Adverse Events and Laboratory Abnormalities.

Incidence of serious adverse events [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]

The percentage of participants experiencing study serious adverse events will be summarized.

Change from baseline in chemistry and hematology parameters [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]

Chemistry and hematology data (using conventional units) will be summarized by the observed data and by the change from baseline. Graded laboratory abnormalities will be defined using the GSI Grading Scale for Severity of Adverse Events and Laboratory Abnormalities.

Change from baseline in log10 HIV-1 RNA [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]

The components of the antiretroviral (ARV) regimen will be selected by the investigator without input from the sponsor. The Antiretroviral Regimen must consist of at least 2 agents, not including the non-nucleoside reverse transcriptase inhibitors (NNRTIs) efavirenz, nevirapine or delavirdine, the protease inhibitors saquinavir, nelfinavir or indinavir, or investigational agents (without sponsor approval).

Eligibility

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Completion of a prior EVG/r treatment study without treatment-limiting toxicity.

Males and females (of childbearing potential ie, not surgically sterile or at least two years post-menopausal) must agree to utilize effective contraception methods (two separate forms of contraception, one of which must be an effective barrier method, or be non-heterosexually active, practice sexual abstinence, or have a vasectomized partner(confirmed sterile)) while on study treatment and for 30 days following the last dose of study drug.

The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.

Exclusion Criteria:

Females who are pregnant or breastfeeding.

Participation in any other clinical trial without prior approval from the Sponsor is prohibited while participating in this trial.

Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements.

Subjects receiving ongoing therapy with contra indicated drugs.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445146